Method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for diagnostic purposes

ABSTRACT

There is provided a method and apparatus for collecting vaginal fluid and exfoliated vaginal cells for medical diagnostic purposes. An absorbent media is placed interlabially or intravaginally. Fluid is collected within the absorbent media. The absorbent media is removed, and the fluid is extracted therefrom. For intravaginal collection, the absorbent media may be placed in a housing having fluid receiving apertures therein. Medical diagnostic testing is performed on the extracted fluid.

BACKGROUND OF THE INVENTION

This invention relates to medical diagnostic testing.

More particularly, it relates to the collection of vaginal fluids andexfoliated vaginal cells for diagnostic purposes.

Currently, the vast majority of clinical diagnostic testing ofbiological fluids utilize serum and urine. It is believed that theUnited States Food and Drug Administration has not approved a clinicaldiagnostic test which utilizes any biological fluid other than wholeblood, serum, plasma, saliva or urine. Tears and sweat are other fluidsbeing used for various non-FDA approved diagnostic purposes, althoughsuch uses have been very limited. These fluids are very different incomposition and their uses in clinical medicine.

The use of gynecological tissue for cancer diagnostic purposes has beenlimited to the traditional PAP Test Cervical Scraping (PTCS method ofcollection) and the subsequent histological smears for cervical cancerscreening. A chemical or immunochemical analysis of non-menstrualvaginal fluid, menstrual fluid and/or the cellular extracts of menstrualfluid for the purpose of disease detection or patient well-being havenot been exploited by the general medical community.

There have been a number of articles written by Dr. Matthew Freund andothers which suggest that one may collect a large quantity of cervicaland endometrial cells from menstrual fluids rather than through thetraditional PTCS method. Dr. Freund found that both ectocervical andother cells collected from the menstrual fluid flow are well preservedfor standard laboratory cytological procedures. They are similar inappearance to cells collected by current clinical methods, and givesimilar reactions to chemicals and stains, and may be analyzed by thesame procedures as cervical smears for PAP testing.

OBJECTS OF THE INVENTION

It is therefore one object of this invention to provide an improvedmethod for collecting vaginal fluid and vaginal cells for diagnosticpurposes.

It is another object of this invention to provide a non-invasive methodfor collecting vaginal fluid and vaginal cells for diagnostic purposes.

It is still another object of this invention to provide anover-the-counter kit for collecting vaginal fluid and vaginal cells fordiagnostic purposes.

SUMMARY OF THE INVENTION

In accordance with one form of this invention, there is provided amethod for collecting vaginal fluid and exfoliated vaginal cells inmenstrual fluid for medical diagnostic purposes. An absorbent media isplaced interlabially or intravaginally. Fluid is collected within theabsorbent media. The absorbent media is removed, and the fluid isextracted therefrom. For intravaginal collection, the absorbent mediamay be placed in a housing having fluid receiving apertures prior toinsertion into the vagina. Medical diagnostic testing is performed onthe extracted fluid.

Preferably the absorbent media used to collect vaginal fluid is aninterlabia pad, such as the pads described in U.S. Pat. Nos. 3,726,277;3,983,873; and 4,196,562 issued to Hirschman and licensed to AthenaMedical Corporation, assignee of the present invention, or the paddescribed in U.S. Pat. No. 4,995,150 issued to Gerstenberger et al andassigned to Athena Medical Corporation. The Hirschman and Gerstenbergeret al patents hereby are incorporated herein by reference.

It is preferred that the absorbent media used to collect exfoliatedvaginal cells from menstrual fluid be of a shape similar to a tampon,but of a different construction and composition. Preferably, the tamponshaped device includes an absorbent core which is at least partiallysurrounded by a porous matrix.

Over-the-counter kits may be provided so that the collection of thefluids may be done by the consumer in the privacy of her home.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter which is regarded as the invention is set forth inthe appended claims. The invention itself, however, together withfurther objects and advantages thereof may be better understood inreference to the accompanying drawings in which:

FIG. 1 is a pictorial view of a fluid collection device which may beused in accordance with this invention and is particularly useful in thecollection of vaginal fluid;

FIG. 2 is a pictorial view of a fluid collection device which may beused in accordance with this invention and is particularly useful in thecollection of vaginal cells from menstrual fluid;

FIG. 3 is a sectional view of the device of FIG. 2;

FIG. 4 is a partial pictorial view of the device of FIG. 2 with aportion of the outer matrix removed;

FIG. 5 is a pictorial view of a collection kit in accordance with thepresent invention;

FIG. 6 is a pictorial view of another collection kit in accordance withthe present invention;

FIG. 7 is a pictorial view of a housing for the fluid collection deviceshown in FIG. 1 or FIG. 2;

FIG. 8 is an exploded partial sectional view of the housing of FIG. 7.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Vaginal fluid and vaginal cells originating from intravaginalsecretions, such as menstrual fluid, can be used to monitor severalimportant clinical parameters, including cervical cancer, candida,chlamydia, trichomonas, bacterial vaginosis, i.e. gardnerella, and thesexually transmitted diseases, including HIV, syphilis, gonorrhea, humanpapilloma virus, and herpes infections. In addition, the fluid extractcan be useful in measuring certain metabolic clinical parameters thathave traditionally been limited to blood collections. Such parameterscan be glucose, cholesterol, pituitary hormones, thyroid hormones,steroid hormones, therapeutic drugs, drugs of abuse, nutritional markers(pre-albumin, etc.), fetal disease markers during pregnancy (placentalprotein markers) and levels of certain unknown metabolites that may becharacterized by immunochemical (ELISA, RIA, FPIA, EMIT) or physical(NMR, HPLC, HPCE, HPTLC, GC-MS or FTIR) diagnostic techniques.

The fluid collection apparatus of the subject invention may be aninterlabia pad constructed in accordance with U.S. Pat. Nos. 3,726,277and 3,983,873 issued to Hirschman. The pad is formed from a fluidabsorbent material, preferably rayon, which has better properties forsample collection than compacted cellulose, which is used in tampons.Other natural or synthetic fibers with similar hydrodynamic propertiesto rayon could be used. The pad is adapted to be inserted into theinterlabia space by the user for absorbing vaginal discharges. The padis securely retained in place despite substantial increases in itsweight due to the absorption of vaginal fluids. The pad has been foundto be safe and extremely comfortable for the user and is non-invasive.

Referring now more particularly to FIG. 1, there is provided interlabiapad 15 which includes an absorbent inner rope 16 covered by outercovering 18. The absorbent inner rope 16 may be made of the sameabsorbent material referred to above. A portion 20 of covering 18extends along the side rope 16 so as to provide a place for the user togrip the pad for insertion into and withdrawal from the interlabiaspace. Preferably opposing sides of the cover are sewn or ultrasonicallysealed together, depending on the type of material, as indicated alongattachment line 22. The pad of FIG. 1 is more fully described in U.S.Pat. No. 4,196,562 issued to Hirschman. It has been found that the padshown in FIG. 1 is useful in collecting vaginal fluids for diagnosticpurposes.

FIGS. 2, 3 and 4 show absorbent device 24 which is shaped like a tampon,but has a different structure and function. Absorbent device 24 includesa soft inner core 25 made of a fluid absorbent material made of a highlyabsorbent, but extractable, material, such as rayon, cellulose, cottonor other natural or synthetic fibers. Core 25 is able to absorb at leastfive times its weight in fluid. Preferably, core 25 is made of rayonfibers to eliminate dehydration and trapping of cellular elements, whichoccur to a greater extent with compacted cellulose materials employed intampons. Device 24 includes an outer covering 27 to enhance itsstability and to permit fluid to freely pass therethrough into core 25.Covering 27 is made of a highly porous material, such as sponge ornylon, and includes a matrix of pores 29 which allows for the collectionof cellular debris without dehydration or inversible trapping within thematrix. The porous matrix allows for a greater ease of extraction andhigh quality of cellular material obtained. Device 24 is insertedintravaginally, in close proximity to the cervix.

Device 24 is also useful as a vaginal fluid collection device,particularly, for collecting blood and fluid from menstrual flow.

In cases where the fluid is to be collected intravaginally, theabsorbent device 15 or 24 may be inserted into an elongated housinghaving a plurality of fluid receiving apertures therein. This may beseen better in reference to FIGS. 7 and 8. Elongated housing 31 includesa lower hollow portion 33 and an upper hollow portion 35. The lowerportion 33 includes a plurality of apertures 37 for permitting fluid toenter the inside of the housing. The inside of the housing receivesabsorbent device 15 or 24. The upper portion of the housing 35 is in theform of a cap. The cap is removably secured to the lower portion of thehousing 33 by engagement with studs 39. The housing with the absorbentmaterial 24 received therein is inserted into the vagina for collectingfluids. Once the fluids are collected, the housing is removed from thevagina, using pull string 42. Opening 41 is provided in the top of thecap. A rod or plunger 44 may be placed into opening 41 and pressedagainst plate or disc 43 within device 24 to compress the fluid ladenabsorbent device and thus, squeeze out the fluids. The fluids will flowback through apertures 37 and into a collection vessel.

The pads 15 are preferably included as a part of a vaginal fluidcollection kit 26, as shown in FIG. 5, containing shipping tubes 28,mailing labels 30 and instructions 32, all housed in box 33. Housing 33may also be included in the kit. Kit 26 is preferably availableover-the-counter or from a physician and may be conveniently used by theconsumer in the privacy of her home. The pad is first insertedinterlabially and remains inserted for a specified amount of time. Whenready, the pad is dropped into a disposable sample container 28containing extraction/preservative solution and is mailed to alaboratory for analysis. Thus there is provided a non-invasive, simple,convenient and private sample collection procedure which allowscollection of vaginal fluids using the kit, with its attendantadvantages over having to go to a physician's office or clinic for acervical scrape, or for blood collection.

Device 24 is particularly adapted to collect exfoliated cells or otherspecimen materials from vaginal fluid. Device 24 is also preferablyincluded in an exfoliated cell collection kit 34, as shown in FIG. 6.Kit 34 includes device 24 and sample vials 36 and 38, containing anextraction buffer and/or preservative solution. The top of the samplevial is sealable. Device 24 and cups are received in box 40. Device 24is inserted into the vaginal tract or labia and allowed tocollect/absorb for short periods or overnight. Device 24 is then removedby the user and placed in sample vial 36 containing the extractionbuffer and preservative. The vial containing the specimen is then sealedand mailed to a testing laboratory. This technique is also anon-invasive, convenient, simple and private method of samplecollection. It is believed that the quantity of cells collected isgreater and the collection is more consistent than that for the PTCSmethod. Use of the extraction buffer, preservative buffer, or both willvary depending on the types of test desired. Additional material neededfor mailing of biohazardous material may be added to the kit.Instructions which contain a patient information sheet to be filled outby the user to be mailed with the sample may also be added to the kit.

Both the PTCS and blood collection methods require a trained healthprofessional to collect the samples and do not offer the advantages ofprivacy and non-invasiveness, as set forth above. In addition, when usedfor cervical cancer detection, the quality of cells obtained by themethod of this invention is comparable to or greater than that of thePTCS for diagnosing cervical cancer. Furthermore, it is believed thatthe consistency of the sample collection is inherently superior usingteachings of this invention over PTCS. The PTCS method can varysignificantly in quality and quantity due to technique variationsbetween health care technicians and the anatomical differences amongpatients. These variations in sample collection using the PTCS methodare believed to be the main reason for the high false negative rateamong cervical cancer tests. The method of this invention does not relyon technique dependent procedures to obtain a representative sample, andas such, is less likely to allow a false negative test to occur. Inaddition, the fluid sample contains certain cellular molecularcomponents, i.e. hemoglobin, that can be measured and then used asinternal qualitative markers to address sample adequacy andstandardization issues.

Thus there is provided a simple, inexpensive and convenient method forthe collection of vaginal fluid and vaginal cells for diagnosticpurposes. The method is non-invasive and kits may be purchased by theconsumer over the counter, resulting in far less expense andinconvenience to the consumer. In addition, it is believed that thediagnostic accuracy will be greatly enhanced, particularly for cervicalcancer detection.

From the foregoing description of the preferred embodiments of theinvention, it will be apparent that many modifications may be madetherein. It will be understood, however, that these embodiments of theinvention are exemplifications of the invention only and that theinvention is not limited thereto. It is to be understood therefore thatit is intended in the appended claims to cover all modifications thatfall within the true spirit and scope of the invention.

We claim:
 1. A kit for collecting vaginal fluid and/or exfoliatedvaginal cells comprising:a housing; said housing receiving at least onefluid absorbent media; said fluid absorbent media being an interlabialpad; said housing further receiving at least one container; saidcontainer for receiving said interlabial pad after said interlabial padhas absorbed an amount of fluid and/or exfoliated cells for delivery ofsaid saturated interlabial pad to a medical diagnostic facility.
 2. Akit as set forth in claim 1, wherein said container includes an amountof extraction solution.
 3. A kit as set forth in claim 2, wherein saidcontainer includes an amount of preservative.
 4. A method for collectingvaginal fluid and/or exfoliated vaginal cells for diagnostic purposescomprising the steps of:placing a fluid absorbent media inside anelongated container; said container having a plurality of fluidreceiving apertures therein; said container including a removable upperportion so as to facilitate the placing of the fluid absorbent mediawithin said container and removal of said fluid absorbent media fromsaid container placing said container intravaginally; collecting fluidin the absorbent media; removing said container from the vagina;extracting fluid from the absorbent media by compressing said fluidabsorbent media within said container so that fluid flows from thecontainer through said at least one aperture; performing medicaldiagnostic testing on the extracted fluid.
 5. A method as set forth inclaim 4, wherein said upper portion includes an aperture therein wherebya rod may be inserted therethrough for compressing said fluid absorbentmedia thereby extracting the fluid from the absorbent media.
 6. Anapparatus for collecting vaginal fluid comprising:a housing; saidhousing including a lower portion having at least one aperture thereinfor permitting vaginal fluid to enter into said housing; said housingfurther including an upper portion forming a removable cap; said housingadapted to receive a fluid absorbent media; said cap having an openingtherein; said lower portion includes a plurality of apertures therein.7. An apparatus for collecting vaginal fluid comprising:a housing; saidhousing including a lower portion having at least one aperture thereinfor permitting vaginal fluid to enter into said housing; said housingfurther including an upper portion forming a removable cap; said housingadapted to receive a fluid absorbent media; said cap having an openingtherein; a rod; said rod adapted to be received through said opening insaid cap for compressing the fluid absorbent media thereby causing saidfluid from said fluid absorbent media to flow out of said housingthrough said at least one aperture in said lower portion.
 8. Anapparatus as set forth in claim 7, further including a plate; said platebeing located between said opening in said cap and the fluid absorbentmedia; said rod contacting said plate for compressing the fluidabsorbent media.
 9. An apparatus as set forth in claim 6, wherein saidlower portion includes a plurality of apertures therein.
 10. A methodfor collecting vaginal fluid and/or exfoliated vaginal cells fordiagnostic purposes utilizing an interlabial pad comprising the stepsof:removing the upper portion of a container; placing the interlabialpad inside the container; placing the container containing saidinterlabial pad intravaginally; said container having a plurality offluid receiving apertures therein; collecting fluid in the interlabialpad; removing the container containing said interlabial pad from thevagina; extracting fluid from the interlabial pad; performing medicaldiagnostic testing on the extracted fluid.
 11. A kit for collectingvaginal fluid and/or exfoliated vaginal cells comprising:a housing; saidhousing receiving at least one fluid absorbent media; said fluidabsorbent media including an inner core and an outer covering; saidouter covering having a visible matrix of pores wherein vaginal cellsmay be collected in said visible matrix of pores; said housing furtherreceiving at least one container; said container for receiving saidabsorbent media after said absorbent media has absorbed an amount offluid for delivery of said saturated absorbent media to a medicaldiagnostic facility.